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United States · US · US:68083-527_daec1549-17b5-483b-8efe-55b936be5174
Dexmedetomidine
In shortageOrange BookUNIISPLATC N05CM18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeN05CM18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680835272525 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
1018WH7F9I
DEXMEDETOMIDINE HYDROCHLORIDE
RxCUI 228054
Orange Book
A202126
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dexmedetomidine Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "1018WH7F9I",
"rxcui": "228054",
"inchikey": "VPNGEIHDPSLNMU-MERQFXBCSA-N",
"display_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"f140de5a-f13d-46b4-a742-049c63e474f5": {
"match": "brand_token",
"title": "DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
"spl_version": "4",
"published_date": "2026-05-29"
}
},
"productid": "68083-527_daec1549-17b5-483b-8efe-55b936be5174",
"productndc": "68083-527",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "202126",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)",
"product_no": "001",
"approval_date": "Aug 20, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
"shortage_reason": "Dexmedetomidine Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "Dexmedetomidine",
"active_ingred_unit": "ug/mL",
"application_number": "ANDA202126",
"marketing_category": "ANDA",
"nonproprietary_name": "Dexmedetomidine",
"start_marketing_date": "20210628",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N05CM18.
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